510(k) · Cleared

Cleared

Smartflow Catheter

K123605510(k) TraditionalCleared Aug 16, 2013268-day reviewClass II21 CFR 882.4100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mri Interventions, Inc. · HCA Catheter, Ventricular

Cleared on Aug 16, 2013 as substantially equivalent to K102101 (Surgivision, Inc., 2011) after a 268-day review. Its family tree reaches back 1 generation to 2011. 1 later device descends from it.

Decided: Aug 16, 2013
Review: 268 days
Class: Class II
Product code: HCA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K102101 (2011). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK102101 Surgivision MR Compatible Ventricular CannulaSurgivision, Inc. · 2011
This deviceK123605 Smartflow CatheterMri Interventions, Inc. · 2013
Descendant · cites it directly · 0 of its ownK161731 Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp. · 2017

Most influential descendants

Showing 1 of 1 · See all

K161731Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp. · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K102101	Surgivision MR Compatible Ventricular Cannula	Surgivision, Inc.	2011	—
0 (this device)	K123605	Smartflow Catheter	Mri Interventions, Inc.	2013	—
+1	K161731	Cleveland Multiport Ventricular Catheter Set	Parker Hannifin Corp.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K123605, 2011–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HCA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K102101	Surgivision MR Compatible Ventricular Cannula Summary page 1 ….4100 Product Code: I-ICA 3. Predicate Device: MRfl Ventricular Caninula, K 102 101 4. Intended Use Statement: The SmartFlowm Flex Ventricular Catheter is intended for injectio…	Surgivision, Inc.	2011	—

Also cleared against K102101: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K161731	Cleveland Multiport Ventricular Catheter Set	Parker Hannifin Corp.	2017	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K161731 (Parker Hannifin Corp., 2017) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K102101.

How does its category compare?

All HCA devices

HCA Catheter, Ventricular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · HCA

1in 2017

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCA

Too few HCA 510(k)s in any year since 2007 to give a median.

Recalls per year · HCA

No recall names HCA since 2007.

Adverse event reports per year · HCA

1in 2021

2007high 19 (2011) · low 0 (2013)2025

MAUDE reports naming product code HCA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	8
2008	0	—	3
2009	0	—	1
2010	0	—	4
2011	0	—	19
2012	0	—	1
2013	1	—	0
2014	0	—	0
2015	0	—	2
2016	0	—	1
2017	1	—	3
2018	0	—	0
2019	0	—	2
2020	0	—	1
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The SmartFlowTm Flex Ventricular Catheter is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. This device is intended for "single patient use only."

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K123605 · printed Nov 4, 2026

Cite this page

510(k) Report. “K123605: Smartflow Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123605

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026